Atroaldo 20 mg: Ficha Técnica, Dosificación y Modo de Uso

Atroaldo 20 micrograms / puff, pressurized inhalation solution.

2. Qualitative and quantitative composition

– Each inhalation contains 21 micrograms of ipratropium bromide monohydrate (equivalent to 20 micrograms of anhydrous ipratropium bromide).
– Excipient(s) with known effect: each inhalation contains 8.4 mg of ethanol.

3. Pharmaceutical form

– Pressurized inhalation solution.

4. Clinical particulars

4.1. Therapeutic indications

– Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

4.2. Posology and method of administration

– ATROALDO is administered only by inhalation.
– The recommended dose is 2 inhalations (equivalent to 40 micrograms of anhydrous ipratropium bromide), 4 times a day.
– A total daily dose of 12 inhalations (equivalent to 240 micrograms of anhydrous ipratropium bromide) should not be exceeded.
– Administration in children should be done under medical recommendation and supervision of an adult.
– Consult a doctor or go to the nearest hospital in case of acute dyspnea or rapid worsening of it.

4.3. Contraindications

– Hypersensitivity to the active substance, to atropine or its derivatives, or to any of the excipients.

4.4. Special warnings and precautions for use

– Patients with cystic fibrosis may be more prone to gastrointestinal motility disorders.
– Immediate hypersensitivity reactions may occur after administration of ATROALDO, such as urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, and anaphylaxis.
– Use with caution in patients with narrow-angle glaucoma and obstruction of urinary flow.
– Isolated cases of ocular complications have occurred when ipratropium bromide has penetrated the eyes due to inappropriate application of an inhalation solution.
– Patients should be instructed on the proper use of the inhalation solution.
– Rinsing the mouth with water after each inhalation is recommended.

4.5. Interaction with other medicinal products and other forms of interaction

– Beta-adrenergic agents and xanthine derivatives may enhance the bronchodilator effect.
– ATROALDO can be administered concomitantly with other drugs used in the treatment of chronic obstructive pulmonary disease without harmful interactions occurring.

4.6. Fertility, pregnancy, and lactation

– The safety of ATROALDO during pregnancy has not been established. The benefit of its use should be weighed against the possible risks to the fetus.
– It is unknown whether ATROALDO is excreted in breast milk. It should be administered with caution to women who are breastfeeding.

4.8. Undesirable effects

– The most common adverse reactions are headache, cough, pharyngitis, paradoxical bronchospasm, dry mouth, and gastrointestinal motility disorders.
– Less frequent adverse reactions include urticaria, anaphylactic reaction, angioedema, accommodation disorders, narrow-angle glaucoma, tachycardia, palpitations, tachycardia

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios cima.aemps.es